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KeloidPhase 1/2NCT05893108

Ethosomal Gel Bearing Losartan 5% for Keloid Treatment

A Phase 1/2 study testing Ethosomal gel bearing losartan 5% and triamcinolone acetonide 10 mg/ml in people with Keloid, run by Yuni Eka Anggraini at 1 site in Indonesia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The objectives are to compare the efficacy of pre and post-treatment and between 5% losartan potassium loaded in ethosomal gel and 10 mg/ml triamcinolone acetonide injection based on the indicator score of The patient and observer scar assessment scale 3.0 (POSAS 3.0), degree of erythema and pigmentation, area size… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Keloid
What is being tested?
Ethosomal gel bearing losartan 5% and triamcinolone acetonide 10 mg/ml
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteIndonesia
Study dates
30 Mar 2024to 30 Oct 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • keloid patients who came to the outpatient clinic of general hospital Syafira Pekanbaru during 2023-2024,
  • age is greater than or equal to 18 year
  • keloid scar than or equal to 25 cm2
  • duration of keloids longer than or equal to 6 months
  • no drug interventions or not currently on keloid medications for the last two months.

Who cannot join

  • subjects who do not understand the rubric of The patient and observer scar assessment scale (POSAS) and were not willing to participate
  • subjects with nodular keloids
  • subjects within antihypertensive therapy, pregnancy, malignancy, history of allergies, active skin lesions or bleeding in the keloid area.
  • subjects in the treatment of keloid within the last month.

Trial locations and contacts

1 site in 1 country.

Anggraini contact

(+62) 0813-6300-9995

yuniea2001@mail.ugm.ac.id

Indonesia1 site

  • Rumah Sakit Syafira

    Pekanbaru, Riau

    Yuni Eka Anggraini

    Yuni Anggriaini

Other trials in Indonesia

About this study

Official title: The Effect of Ethosomal Gel Bearing Losartan 5% on The Patient and Observer Scar Assessment Scale Score, Degree of Erythema and Pigmentation, Surface Area, Thickness and Pliability of Human Keloids

The objectives are to compare the efficacy of pre and post-treatment and between 5% losartan potassium loaded in ethosomal gel and 10 mg/ml triamcinolone acetonide injection based on the indicator score of The patient and observer scar assessment scale 3.0 (POSAS 3.0), degree of erythema and pigmentation, area size, thickness and density of human keloids.

Read the detailed description

After being informed about the study and the associated risks and benefits, participants will be randomly allocated to one of two groups, each consisting of 23 individuals. After being informed about the study and the associated risks and benefits, participants will be randomly allocated to one of two groups, each consisting of 23 individuals. One group will receive the topical application of 5% losartan gel, while the other will receive an injection of triamcinolone acetonide 10mg/ml. After being informed about the study and the associated risks and benefits, participants will be randomly allocated to one of two groups, each consisting of 23 individuals. To measure the subjective and objective changes that occur in the keloid before and after treatment, outcome assessors will be blinded. Measurements will be taken four times over the course of three months.

Conditions
Keloid
Being tested
Ethosomal gel bearing losartan 5%, triamcinolone acetonide 10 mg/ml
Keywords
Angiotensin II, Angiotensin II blocker, 5 % Losartan Gel, 10 mg/ml Triamcinolone acetonide, Keloid
Medical subject headings
Keloid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ethosomal gel bearing losartan 5%Drug

    A pharmaceutical company with a good manufacturing practice certificate is developing ethosomal gel bearing losartan 5%

  • triamcinolone acetonide 10 mg/mlDrug

    Also called TA 10 mg/ml

    intralesional injection

Study groups in NCT05893108
Study groupRoleWhat they receive
LosartanExperimentalethosomal gel bearing losartan 5% applied two times a day for three consecutive months on keloids
Receives: Drug: Ethosomal gel bearing losartan 5%
TriamcinoloneActive comparatorIntralesional injection of triamcinolone acetonide 10 mg/ml every two weeks for three consecutive months on keloid
Receives: Drug: triamcinolone acetonide 10 mg/ml

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The patient and observer scar assessment scale score (POSAS 3.0)

    The Patient and Observer Scar Assessment Scale 3.0 consists of sixteen items of the patient questionnaire (PSAS) with maximum and minimum values are 80 and 16, consecutively; and seven items of the observer questionnaire (OSAS) with maximum and minimum values are 35 and 7, consecutively. The lower score, the better result of the keloid.

    Measured: change from baseline the POSAS score at 4,8, and 12 weeks, consecutively.

Secondary outcomes (4)

  1. Degree of erythema and hyperpigmentation

    The colors are taken using dermoscopy and quantifiably analysed using image analysis ImageJ

    Measured: change from baseline the degree of erythema and hyperpigmentation at 4, 8 and 12 weeks, consecutively.

  2. the width of the keloid surface area (mm2)

    The surface area is taken by digital photography and quantifiably analysed using image analysis ImageJ

    Measured: change from baseline width of keloid surface area at 4, 8 and 12 weeks, consecutively.

  3. The thickness of keloid (mm)

    The thickness of the keloids is assessed using high-frequency ultrasonography

    Measured: change from baseline thickness of keloid at 4, 8 and 12 weeks, consecutively.

  4. The degree of pliability of keloid (durometer unit)

    The pliability of keloids is assessed using durometer shore type oo (Teclock Japan)

    Measured: change from baseline pliability at 4, 8 and 12 weeks, consecutively.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2023
  2. Study start30 Mar 2024 (estimated)
  3. Primary completion30 Sep 2024 (estimated)
  4. Study completion30 Oct 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two groups received different treatment at the same time. Both outcomes were measured at the same time before and after treatment with 4 measurements.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05893108
Sponsor's protocol ID
CT0012023
Status last verified
Nov 2023
First submitted
24 May 2023
Last updated
5 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data obtained through this study may be provided to qualified researchers with academic interest in keloid treatment. Data or samples shared will be coded, with no protected health information included. Approval of the request of the dataset is prerequisites to the sharing of data with the requesting party.

Publications

  • Bock O, Schmid-Ott G, Malewski P, Mrowietz U. Quality of life of patients with keloid and hypertrophic scarring. Arch Dermatol Res. 2006 Apr;297(10):433-8. doi: 10.1007/s00403-006-0651-7. Epub 2006 Mar 10.

    PubMed 16528552

  • Elsaie ML. Update on management of keloid and hypertrophic scars: A systemic review. J Cosmet Dermatol. 2021 Sep;20(9):2729-2738. doi: 10.1111/jocd.14310. Epub 2021 Jul 3.

    PubMed 34169622

  • Steckelings UM, Czarnetzki BM. The renin-angiotensin-system in the skin. Evidence for its presence and possible functional implications. Exp Dermatol. 1995 Dec;4(6):329-34. doi: 10.1111/j.1600-0625.1995.tb00056.x.

    PubMed 8608339

  • Silva IMS, Assersen KB, Willadsen NN, Jepsen J, Artuc M, Steckelings UM. The role of the renin-angiotensin system in skin physiology and pathophysiology. Exp Dermatol. 2020 Sep;29(9):891-901. doi: 10.1111/exd.14159.

    PubMed 32697884

  • Hedayatyanfard K, Ziai SA, Niazi F, Habibi I, Habibi B, Moravvej H. Losartan ointment relieves hypertrophic scars and keloid: A pilot study. Wound Repair Regen. 2018 Jul;26(4):340-343. doi: 10.1111/wrr.12648. Epub 2018 Oct 25.

    PubMed 30099811

  • Khodaei B, Nasimi M, Nassireslami E, Seyedpour S, Rahmati J, Haddady Abianeh S, Motavalli Khiavi F. Efficacy of Topical Losartan in Management of Mammoplasty and Abdominoplasty Scars: A Randomized, Double-Blind Clinical Trial. Aesthetic Plast Surg. 2022 Oct;46(5):2580-2587. doi: 10.1007/s00266-022-02935-2. Epub 2022 May 25.

    PubMed 35614156

  • Anggraini YE, Trisnowati N, Martien R, Danarti R. A randomised clinical trial study assessing the efficacy of 5% losartan potassium loaded in ethosomal gel to treat human keloids: a trial protocol. Trials. 2024 Jan 2;25(1):12. doi: 10.1186/s13063-023-07880-2.

    PubMed 38167064

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Ethosomal gel bearing losartan 5% and triamcinolone acetonide 10 mg/ml in people with Keloid, run by Yuni Eka Anggraini at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Anggraini ((+62) 0813-6300-9995, yuniea2001@mail.ugm.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The patient and observer scar assessment scale score (POSAS 3.0) (time frame: change from baseline the POSAS score at 4,8, and 12 weeks, consecutively.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05893108, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.

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